- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01451580
Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast Cancer
October 12, 2011 updated by: TTY Biopharm
A Phase II Study of Pegylated Liposomal Doxorubicin (Lipo-Dox) Combined With Cyclophosphamide /5-Fluorouracil as Second Line Chemotherapy in the Treatment of Metastatic Breast Cancer
To determine the overall objective response rate of pegylated liposomal doxorubicin (Lipo-Dox)combined with cyclophosphamide/5-FU as second-line treatment in patients with metastatic breast cancer.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linko, Taiwan
- Recruiting
- CGMH
-
Contact:
- Wang, AN
- Phone Number: +8862-2545-3105
- Email: monicachang@tty.com.tw
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Principal Investigator:
- Chang
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- histologically proved breast cancer with metastatic disease
Exclusion Criteria:
- life expectancy less than 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hsien-Kun Chang, Chang Gung Memorial Hospital, Lin-Kou Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 12, 2011
First Posted (ESTIMATE)
October 13, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 13, 2011
Last Update Submitted That Met QC Criteria
October 12, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LD0411
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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